Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05811364
NA

The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

Sponsor: W.L.Gore & Associates

View on ClinicalTrials.gov

Summary

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

244

Start Date

2023-10-17

Completion Date

2032-01-31

Last Updated

2025-04-16

Healthy Volunteers

No

Interventions

DEVICE

Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.

DEVICE

Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent

Treatment of target lesions in the common and/or external iliac arteries by stenting with a commercially available bare metal stent that is approved for treatment of the disease.

Locations (7)

North Suburban Medical Center

Denver, Colorado, United States

Radiology and Imaging Specialists of Lakeland

Lakeland, Florida, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Krankenhaus der Barmherzigen Brüder

Regensburg, Germany

Rijnstate Hospital

Arnhem, Netherlands

Auckland City Hospital

Auckland, New Zealand